Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087859
Company: CMP PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SPS SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/08/1982 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/2011 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

03/03/2011 SUPPL-24 Labeling

Label is not available on this site.

03/03/2011 SUPPL-23 Labeling

Label is not available on this site.

03/18/2004 SUPPL-20 Labeling

Label is not available on this site.

11/30/2000 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

05/31/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/12/1991 SUPPL-13 Labeling

Label is not available on this site.

07/18/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/16/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/12/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/27/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

SPS

SUSPENSION;ORAL, RECTAL; 15GM/60ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KIONEX SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription No AA 040028 PADDOCK LLC
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription No AA 090590 PADDOCK LLC
SODIUM POLYSTYRENE SULFONATE SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription No AA 089049 WEST-WARD PHARMS INT
SPS SODIUM POLYSTYRENE SULFONATE 15GM/60ML SUSPENSION;ORAL, RECTAL Prescription No AA 087859 CMP PHARMA INC

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